Page 186 of 192
17. QLCI2 (MEDLINE
®
CARELINE
®
)
The Quad Load Cell Interface 2 (QLCI2) for the hospital and care segment is a scale system accessory with weighing capabilities and Out of Bed
functionality.
The housing, makes the QLCI2 easy to mount by unique slide-on brackets and has an IPX6 Washable DURA
TM
ingress protection.
The QLCI2 supports the LINAK OpenBus
TM
system offering a high level of customisation.
LINAK A/S delivers the OpenBus™ system only and is not responsible for any products (i.e. products from 3
rd
party suppliers) other than
LINAK products or the compatibility of such products with the LINAK OpenBus™ system.
Usage
• Operation temperature: + 5 °C to + 40 °C
• Storage temperature: - 10 °C to + 50 °C
• Relative humidity: 20% to 80% - non-condensing
• Atmospheric pressure: 700 to 1060 hPa
• Approvals IEC60601-1
ANSI/AAMI ES60601-1
CAN/CSA-22.2 No 60601-1
EN 45501 / OIML R76
EU type examination according to 2014/31/U
• Compatibility: All OpenBus
control boxes
• Flammability rating: UL V0
• Latex free: Yes
Approvals
An OEM application approval according to EN45501
Typically the LINAK Weighing Solution will be classified as a “non-automatic weight” system.
If a LINAK LINAK Weighing Solution system is applied to a bed AND classified as such, the system MUST be “first-time” verified and sealed.
The verification and sealing is typically carried out in one of two ways:
1. Verification by the Bed manufacturer himself.
It prescribes that the manufacturer is certified to carry out the verification.
The certification can be obtained through a Notified Body that performs auditing and approval of the procedures and the quality system in the
manufacturing company.
An example from Denmark:
’DS Certificering’ is the only Notified Body in Denmark, certified to carry out approvals of quality systems for manufacturing and calibration of
‘non-automatic weight’ systems. Within Europe it is however possible to use any other Notified Body from one of the EU member states.
When certified the Bed manufacturer obtains a type approval certificate to prove they are certified to manufacture and calibrate their own “non-
automatic weight” system.
2. Verification by ”first-time” verification Bodies.
In Denmark there are three Notified Bodies available for the verification and sealing of the application:
Force Technology, Dansk Kalibreringsteknik and Trescal.
Again any other Notified Body from an EU member state can be used.
“First-time” verification can take place at either the manufacturer or at the destination of use.
Requirements in both situations:
• The Type Approval Certificate number MUST be marked at the label on the weight unit.
• The Type Approval Certificate must be issued according to and including reference to the Directive for “non-automatic weights” 2009/23/EC
(new non-modified version of 90/384/EEC).
To Next Page
Loading...
Need help?
General
